Kornimate/medical-research-clean huggingface dataset:
quality of life, symptoms and treatment satisfaction in adult patients with relapsed and/or refractory multiple myeloma, receiving ixazomib (ninlaro®) in combination with lenalidomide and dexamethasone in a real world setting: pilot study

Conditions: Relapsed and/or Refractory Multiple Myeloma

Summary: the purpose of this pilot study is to examine changes in patient-reported outcomes in patients with rrmm receiving triple therapy with ixazomib in combination with lendex in a real world setting as well as to analyze clinical outcomes and safety of this treatment modality.


Eligibility criteria:
inclusion criteria: * adult patients with confirmed diagnosis of rrmm * at least 18 years of age at the time of treatment start * patients who have received at least one prior therapy and who are suitable for treatment with ixazomib in combination with lendex * patients who gave informed consent * patients who are capable to fill out questionnaires * patients with expected life duration of at least 6 months exclusion criteria: * patients currently enrolled in any other clinical trials * patients with contraindications to ixazomib in accordance with instruction for use.

Keywords: quality of life
ilioinguinal block in laparoscopic inguinal hernia repair

Conditions: Post Operative Pain as Estimated by the Sue of the VAS Score

Summary: this study is undertaken to clarify whether intraoperative blockage with 40 ml of ½ % marcaine© of the nerves in the ilio-inguinal canal may decrease postoperative pain after laparoscopic inguinal hernia repair. patients will be randomised to injection of marcaine© og a needle prick per-operatively. pain will be estimated using the vas score in: 1. the wound 2 the abdomen 3 the shoulder scoring will be performed: 1. pre-operatively 2. 1 hour postoperatively 3. at discharge from the hospital d day 1,2 and 3 post op e. 1 year post op

as above

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 year 2. informed consent 3. a diagnosis of an inguinal hernia 4. asa group ≤ 3 5. bmi ≤ 35 exclusion criteria: 1. communication problems 2. no consent 3. open procedure (not laparoscopic) 4. asa-group 4 5. use of steroid or immunosuppressive tretament 6. regular morphine use.

Keywords: inguinal hernia, postoperative pain, localanesthesia, nerve blockage
evaluation of percutaneous treatment by cryoablation of unifocal invasive breast carcinoma in menopausal women with indication of lumpectomy

Conditions: Carcinoma, Ductal, Breast; Menopausal

Summary: the primary objective of this monocentric and feasibility study is to review the efficacy of cryotherapy in the treatment of unifocal mammary carcinomas in post-menopausal patients, with lumpectomy indication. the efficacy is defined by the rate of success of cryotherapy procedures. for each one of those evaluated process, an success will be defined on the tumor sample of lumpectomy by the absence of viable tumour cells. on the basis of our expertise, it seems interesting to propose this experimental procedure to patients as described above.


Eligibility criteria:
inclusion criteria: * non inflammatory unilateral and unifocal breast cancer with indication of lumpectomy * menopausal women with age \> 55 years * tumor size \<= 15 mm by ultrasonography * histological confirmation (by biopsy) of invasive ductal carcinoma with sbr (scarff-bloom-richardson) grade (modified by ellis \& elston) 1 or 2; hormone receptors positive (estrogen receptor and/or progesterone receptor) and negative human epidermal growth factor receptor (her2) * good lesion boundary with ultrasonography and mri * minimal distance of 5 mm between the skin and the tumor * performance status 0-1 * ability to understand and willingness to sign a written informed consent document * covered by a medical insurance * signed informed consent exclusion criteria: * invasive lobular carcinoma * tumor with retro-nipple location * extended microcalcifications (\> 15 mm) with mammography * xylocaine allergy * patient deprived of freedom
anhydroglucitol in children with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: the investigators will measure blood levels of 1,5-anhydroglucitol in children with type 1 diabetes and correlate them with parameters related to functional beta-cell mass in diabetic patients. the values will be compared to those obtained in healthy volunteers. children with newly diagnosed diabetes as well as children with longstanding disease will be included. the aim of the study is to test the validity of 1,5-anhydroglucitol as a novel biomarker of beta-cell mass and function in type 1 diabetes.

one-center prospective exploratory pilot study performed in collaboration between the pediatric endocrine and diabetology unit of the university hospitals of geneva (hug) and prof. pierre maechler, diabetes center of the faculty of medicine, university of geneva switzerland. 1,5-anhydroglucitol (1,5-ag), a deoxyhexose present in almost all foods and forming a stable pool in human subjects, has recently been found to be correlated with functional beta-cell mass in two different mouse models of beta-cell dysfunction leading to diabetes. the decline of this biomarker precedes the development of hyperglycemia in lean b-phb2 -/- and obese db/db diabetic mice, where beta-cell loss occurs through two different mechanisms. additional studies have shown a correlation of 1,5-ag levels with risk of progression of type 1 diabetes (t1dm) in auto-antibody positive children, as well as with glycaemic control in patients with type 2 diabetes. the present project will analyse the correlation between functional beta-cell mass and the circulating levels of 1,5-ag in children with t1dm. this should contribute to the evaluation of a novel biomarker of beta-cell mass and function in t1dm.

Eligibility criteria:
inclusion criteria: * type 1 diabetes with positive autoantibodies against islets, insulin, islet antigen 2 (ia2), glutamic acid decarboxylase (gad) 65 or zinc transporter (znt)8. * treatment with continuous subcutaneous insulin infusion (csii) with or without automated insulin delivery (aid). * monitoring with a continuous glucose measurement system (cgms) or flash glucose monitor (fgm). * patient willing to keep the same type of cgms or fgm during the year of observation * ability to give informed consent as documented by signature exclusion criteria: * patients treated with multiple daily injections (mdi) or not willing to wear a cgms of fgm * patients changing the type of cgms during the course of the study.
femoral nerve block: anatomical insertion point - a prospective randomised double-blind controlled trial

Conditions: Femoral Nerve Disease

Summary: nerve blocks are an effective way to control pain after surgery. there are two major nerves that provide sensation to the knee: the femoral nerve provides sensation to the front of the knee and sciatic nerve provides sensation to the back of the knee. the femoral nerve has two branches. to locate the nerve, we use a machine called (nerve stimulator) which is attached to the needle used for nerve block. use of a nerve stimulator is standard practice for this procedure. ultrasound is being increasingly used to locate nerves but is not used universally. we will use the nerve stimulator and ultrasound to locate the femoral nerve but patients will randomly be selected to enter a group looking at the stimulation of one or the other branches of the femoral nerve. the two branches when stimulated produce different muscle contractions in the thigh. we do not know from research which is the optimal contraction to position the needle to get the best block. after the knee replacement patients will still have the same analgesic medication available as patients would have received if they were not in the study.

to determine if needle insertion at the inguinal crease with stimulation of sartorius muscle (anterior branch) causes an equivalent block to the classical method with stimulation of the quadriceps femoris muscle (posterior branch), for femoral nerve blockade. to test this hypothesis, we plan to conduct a randomised controlled double-blind study comparing success of femoral never block (motor and sensory) using sartorius twitch versus quadriceps femoris twitch as an end point. we will also evaluate the local anesthetic distribution under the facia iliaca sheath using ultrasound imaging. methods: following institutional ethical approval and obtaining written informed consent, we plan to recruit 60 patients aged 18-80, asa i-iii scheduled to undergo unilateral total knee arthroplastly in this prospective, randomised, double blinded controlled trial.

Eligibility criteria:
inclusion criteria: * patients aged 18-80 * asa status i-iii * unilateral total knee arthroplasty patients exclusion criteria: * patients with a history of significant medical or psychiatric problems * patients with bmi \> 35 * unable to cooperate with the study protocol or unable to understand english * had allergy to local anaesthetics or fentanyl * prior surgery in the inguinal region * sensory or motor disease * diabetic neuropathy.

Keywords: fnb femoral nerve sartorius twitch quadriceps twitch analgesia anesthesia
long-term study of tak-875

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to evaluate the safety and efficacy of long-term treatment with tak-875 in diabetic patients.


Eligibility criteria:
inclusion criteria: 1. the participant is an outpatient. 2. the participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. exclusion criteria: 1. the participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease. 2. the participant is considered ineligible for the study for any other reason by the investigator or sub-investigator.

Keywords: drug therapy
belimumab in patients with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: the beliles-geas project pretends to obtain an extensive data registry of patients with systemic lupus erythematosus (sle). the main objective is to create a national sle patients registry treated with belimumab to describe effectiveness and safety of intravenous (iv) or subcutaneous (sc) belimumab in patients with active sle treated in the spanish departments of internal medicine in a real-life setting. this research project aspires to cover the vast majority (if not the whole) of sle patients treated with belimumab in all of the spanish departments of internal medicine.

the goal of beliles-geas registry is to create an observational, non-randomized, non-controlled, national multicenter prospective and retrospective cohort with the aim to explore the real performance, with its lights and shadows, of belimumab, either iv or sc, in a real-world population of lupus patients. the intention is to perform a longer-term follow up, so that the measure of hard outcomes, such as improvement in mortality, could be feasible, but also reliable data regarding the safety profile could be recorded. in order to achieve that, the following variables will be included: individual criteria as part of 2019 eular/acr, slicc or acr 1997 classification criteria, gender, age at diagnosis, age at symptoms onset, duration of the disease, age at first belimumab administration, mean time of follow-up prior to, and from belimumab administration, complete medical history including other systemic autoimmune diseases, type/s of organ/systems affected by sle, prior immunosuppressants received, number of flares 2 years prior belimumab onset, number of medical visits, number of days of sick leave, type of disease, treatment and laboratory data. as a measure of damage, systemic lupus international collaborating clinics-damage index (slicc-di) score will be calculated at baseline and at 12, 18, 24 months and yearly of follow-up. all centers will be requested to provide the slicc-di calculated annually of the last five years before the initiation of belimumab, when available. the efficacy will be evaluated as time to reach any of the definition of remission included in the doris (definitions of remission in sle) consensus, or lldas (lupus low disease activity state). regarding the safety of belimumab in real-world setting, it will be defined and evaluated by documenting adverse events.

Eligibility criteria:
inclusion criteria: 1. fulfillment of the 2019 eular/acr classification criteria for sle, slicc classification criteria, 1997 american college of rheumatology (acr) revised criteria for sle or patients with only 3 criteria but sle diagnosed according to the clinical judgment of the treating physician. 2. age of 18 years or more. 3. having received at least one dose of intravenous or subcutaneous belimumab according the physician criteria regardless the clinical/immunological response. 4. signed informed consent. exclusion criteria: 1) negative from the patient to participate in the study.

Keywords: systemic lupus erythematosus sle belimumab
comparison of the new algorithm of stop-bang in the detection of severe osa patients

Conditions: Apnea, Sleep

Summary: the aim of this study was to compare the ability of clinical scores (p-sap, osa50, des-osa, stop-bang with former algorithm, and stop-bang with new algorithm).

severe osa (obstructive sleep apnea) patients are at higher risk of postoperative complications. stop-bang has been proposed to detect osa patients. it has been validated. new algorithm of stop-bang was proposed by the end of 2016. this aim of this study was to evaluate the ability of this new algorithm to detect severe osa patients (patients with more than 30 events per hour). the new algorithm was also compared in this same ability with three others clinical score (p-sap, osa50 and des-osa).

Eligibility criteria:
inclusion criteria: * all patients in the preoperative anesthesia visit between 01/08/2016 and 31/12/2017 exclusion criteria: * patient's refusal
a study of atezolizumab in locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract

Conditions: Urinary Tract Cancer

Summary: this phase iiib, multicenter study will assess the safety of atezolizumab as second- to fourth-line treatment for participants with locally advanced or metastatic urothelial or non-urothelial cancer of the urinary tract in addition to evaluate the efficacy of atezolizumab and potential tumor biomarkers associated with atezolizumab.


Eligibility criteria:
inclusion criteria: * participants with histologically documented locally advanced (tumor \[t\] 4b, any node \[n\]; or any t, n 2-3) or metastatic (m1, stage iv) urothelial or non-urothelial carcinoma of the urinary tract * participants with measurable and/or non-measurable disease according to recist v1.1 * participants must have progressed during or following treatment with at least one prior (and not more than 3) treatments for inoperable, locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract * if available, a representative formalin-fixed paraffin-embedded (ffpe) tumor specimen block should be submitted * eastern cooperative oncology group (ecog) performance status 0, 1 or 2 exclusion criteria: * treatment with more than three prior lines of systemic therapy for inoperable, locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract * treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 4 weeks prior to study treatment initiation 1. participants who were in another clinical trial with therapeutic intent within 4 weeks of study treatment initiation but were not on active drug in that prior trial are eligible 2. participants who were in another clinical trial with therapeutic intent within 4 weeks of study treatment initiation but were in the follow-up phase of that prior trial and had stopped receiving active drug 4 or more weeks before study treatment initiation are eligible * malignancies other than the one studied in this protocol within 5 years prior to cycle 1, day 1 * evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol * significant renal disorder indicating a need for renal transplant
insulet artificial pancreas evaluating meal performance and moderate exercise (ide2)

Conditions: Type 1 Diabetes Mellitus

Summary: to assess the safety and performance of the insulet ap (artificial pancreas) system, using the omnipod® insulin management system, dexcom g4 share® ap system and personalized model predictive control algorithm in adults with type 1 diabetes consuming high fat meals and undertaking moderate intensity exercise.

the two-part study schedule consists of a 7±1 day outpatient, open-loop phase, followed by one 54-hour, hybrid closed-loop phases conducted in a supervised crc or hotel/rental house setting.

Eligibility criteria:
inclusion criteria: 1. age at time of consent 18.0 to 65.0 years 2. diagnosed with type 1 diabetes for at least one year. diagnosis is based on investigator's clinical judgment. 3. total daily dose (tdd) of insulin ≥0.3 units/kg/day and a1c \>6% at screening 4. currently using an insulin pump with u-100 rapid-acting insulin analogs and on pump therapy for at least 6 months prior to study start 5. willing to use the study cgm device for the duration of the study 6. willing to use the omnipod® insulin management system during the study 7. willing to perform all fingerstick bg testing with the study-approved glucose meter at the frequency specified in the study protocol 8. willing to abide by meal recommendations for breakfast, lunch and dinner during the study 9. willing to participate in moderate intensity exercise for up to 45 minutes if taking part in option b 10. willing to refrain from use of acetaminophen and supplemental vitamin c (\>2000 mg/daily) for the entire duration of participation in the study 11. willing and able to sign the informed consent form (icf) exclusion criteria: 1. a1c \>10% at the screening visit 2. one or more episodes of severe hypoglycemia requiring emergency room (er) visit or hospitalization within the past 6 months 3. hypoglycemic unawareness as determined by a score of ≥4 "r" responses on the clarke questionnaire 4. one or more episodes of diabetic ketoacidosis requiring er visit or hospitalization within the past 6 months 5. used non-insulin anti-diabetic medication within last 30 days 6. pregnant or lactating, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, iud or implant) 7. dermatological conditions at the proposed sensor wear sites that in the investigator's opinion could preclude ability to wear the pod and/or the dexcom sensor 8. current or known history of cardiovascular disease, arrhythmia, myocardial infarction (mi) or stroke. an electrocardiogram (ecg) must be obtained within 6 months. 9. currently undergoing systemic treatment with steroids or immunosuppressive medication 10. current illness that would interfere with participation in the study 11. currently participating in another clinical study using an investigational drug or device 12. recent (within the preceding 30 days) participation in a clinical study using an investigational drug.

Keywords: t1d, omnipod
safety and immunogenicity of quadrivalent influenza mrna vaccine mrt5410 in adult participants 18 years of age and older

Conditions: Influenza Immunization

Summary: the purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (im) injection of up to 3 dose levels of quadrivalent influenza mrna vaccine mrt5410 compared to an active control (qiv sd, qiv hd \[adults ≥ 65 years of age only\], or riv4) in adults 18 years of age and older.

approximately 12 months

Eligibility criteria:
inclusion criteria: * aged 18 years on the day of inclusion (us) and aged 21 years on the day of inclusion (puerto rico) * a female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: is of non-childbearing potential. to be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile or is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration. exclusion criteria: * known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * previous history of myocarditis, pericarditis, and / or myopericarditis * self-reported thrombocytopenia, contraindicating im vaccination based on investigator's judgment * bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating im vaccination based on investigator's judgment * moderate or severe acute illness / infection (according to investigator's judgment) or febrile illness (temperature ≥ 38.0°c \[≥ 100.4°f\]) on the day of vaccination. a prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided * self-reported or documented seropositivity for human immunodeficiency virus, hepatitis b virus, or hepatitis c virus note: the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
safety, tolerability, and efficacy of a dose reduction strategy based on bictegravir/emtricitabine/tenofovir alafenamide in virologically suppressed hiv-infected adults

Conditions: HIV Infections

Summary: this is a phase iv, unicentric, open, pilot, randomized, controlled trial to evaluate bictegravir/ftc/taf. the study will be developed at a single clinical care centre:hospital clínic de barcelona, barcelona, spain. the aim of this study is to assess the feasibility of dose redutions of bictegravir/ftc/taf in virologically suppressed hiv-infected adults on betaf once daily. the reduction of drug exposure will have a significant positive impact on parameters reflecting potential toxicities associated with bictegravir or tenofovir.

the primary objectives are: 1. to assess viral efficacy of the reductions of betaf regimen dose at 12 weeks (on-treatment and intent-to-treat populations). 2. to asess viral efficacy of the reduction of betaf regimen dose at 48 weeks (on-treatment and intent-to-treat populations).

Eligibility criteria:
inclusion criteria: * stable and asymptomatic hiv-infected adults (≥18 years) on betaf once daily for at least the previous 6 months. * plasma hiv-1 rna less than 50 copies/ml for at least the previous 6 months. * cd4 cell counts greater than 350 cells/ml at the time of consideration for the study. * women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods. * patients agreed to participate. exclusion criteria: * prior virological failure to any antiretroviral regimen or documented. * any diagnosis of psychiatric illness. * alcohol abuse or illicit drug consumption (based on their past medical history and specific questions at the time of recruitment). * patients co-infected with hiv and active hepatitis b or c virus. * any other condition at the doctor's discretion that did not allow ensuring a correct adherence.